FDA · Enforcement report ·
FDA class II recall for specific amlodipine/olmesartan tablets
The FDA classified a recall for certain amlodipine and olmesartan medoxomil tablets because the medicine amounts did not meet specifications.
If you take amlodipine and olmesartan medoxomil tablets 10 mg/20 mg (30 tablets per bottle), made by Alkem Laboratories Ltd. and distributed by Ascend Laboratories, LLC, this recall may affect you.
The Food and Drug Administration (FDA) says these tablets failed dissolution specifications and that the olmesartan medoxomil content was below specifications (dissolution is how well the tablet releases medicine).
What changes tomorrow depends on whether you have this specific bottle in your home or are using it through your prescription.
Follow the notice’s recall instructions for your specific product (NDC 67877-500-30) to reduce the risk of taking medicine that did not meet specifications.
What to do
- Follow the recall instructions for amlodipine and olmesartan medoxomil tablets (NDC 67877-500-30).